Associate Manager, Clinical Data Management

Position Summary

The Associate Manager, Clinical Data Management will support data management activities for CRISPR studies across all stages of clinical drug development. Working closely with clinical study teams and cross functional stakeholders, they will help ensure that data capture systems, processes, and documentation produce accurate, consistent, complete, and high-quality clinical data. The role will include clinical data review, query management, and data reconciliation, with additional responsibilities spanning data management documentation, user acceptance testing, third-party vendor data, and GCP inspection readiness.

Responsibilities

• Plan, coordinate, and manage data management tasks and timelines.
• Collaborate with internal cross functional management to ensure all stakeholders' needs are addressed.
• Lead the development of data management documentation including CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third-party vendor data specifications; Coordinate related reviews with cross functional team(s).
• Ensure proper filing and documentation of clinical data management documents.
• Lead and participate in UAT of clinical data management systems.
• Lead and participate in clinical data review and data reconciliation.
• Prepare content and participate in study team meetings.
• Contribute to departmental SOP and process development/improvement and integration of technology.
• Support GCP inspection readiness.

Minimum Qualifications

• Bachelor's Degree in a health-related field.
• 4-6+ years of clinical data management experience at Sponsor, CRO, and/or Investigative site.
• Knowledge and experience with Microsoft applications including Word, MS Project, PowerPoint.
• Knowledge and experience with major EDC databases including Medidata Rave, Veeva, etc.
• Experience developing reports using J-Review, BOXI, and/or other CDM reporting tools, including data visualization software.
• Knowledge and experience with CDASH/SDTM/CDISC standards.
• Experience working with central and specialty labs/vendors.
• Knowledge of medical terminology and medical coding dictionaries including MedDRA and WHODrug.
• Familiarity with GCP, ICH, and FDA requirements as applicable for Clinical Data Management.
• Able to manage multiple initiatives and shifting priorities within a small company environment.
• Strong analytical and problem-solving skills that meet or improve the status quo.
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
• Excellent written and oral communication skills.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Preferred Qualifications

• Experience with global studies using an outsourced CRO model.
• Experience in early phase clinical drug development including first-in-human studies.
• Experience with drug development and management of data in rare genetic diseases, in vivo treatments, and/or CAR-T cell therapies.